Device recalls
Recall records from FDA, newest initiation date first.
Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.
Data as of , the FDA export date. FDA medical device recall database
| Recall number | Class | Product | Recalling firm | Product code | Initiated |
|---|---|---|---|---|---|
| Z-1134-04 | CryoValve, Aortic Valve | Artivion, Inc. | MIE | ||
| Z-1383-04 | iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing... | Independence Technology, LLC | IMK | ||
| Z-1052-04 | TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm). On August... | Boston Scientific Corporation | NIQ | ||
| Z-0705-05 | DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of... | Diasorin Inc. | LCI | ||
| Z-0676-05 | PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent... | Diasorin Inc. | DHN | ||
| Z-1128-04 | HA Hip Stem, cementless | Encore Medical, LP | JDI | ||
| Z-1118-04 | Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033. | Nichols Institute Diagnostics | MRG | ||
| Z-1061-04 | ACCU-CHEK Inform base unit; catalog no. 3035131. | Roche Diagnostics GmbH | NBW | ||
| Z-1060-04 | ACCU-CHEK Inform meter; catalog No. 3035123. | Roche Diagnostics GmbH | NBW | ||
| Z-1239-04 | Battery-operated Cautery High Temperature, fine/Loop/ Vasectomy Tip | Apyx Medical Corporation | HQP | ||
| Z-1078-04 | Portex Hypodermic Needle-Pro Syringe and Needle 1ml/LS Small Gauge Safety 27 g x... | Abbott Medical | FMI | ||
| Z-1221-04 | MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020 | Integra LifeSciences Corporation | HBL | ||
| Z-1238-04 | Battery-operated Cautery Low Temperature, fine/elongated Tip | Apyx Medical Corporation | HQP | ||
| Z-1158-04 | RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use. | Revvity Health Sciences, Inc. | JBD | ||
| Z-0986-04 | MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200R40 (mobile) and PW200R40 (wall... | Minxray Inc | DS-21 | ||
| Z-0985-04 | MinXray P200R24 Stationary Podiatry X-Ray System, Model PS200+, MinXray, Inc., 3611... | Minxray Inc | DS-22 | ||
| Z-1301-04 | ConMed Stealth coated Laparoscopic Electrodes with 4mm Pin (60-5158 series). Cat... | ConMed Corporation | GEI | ||
| Z-1090-04 | Hill-Rom brand TotalCare Bed System; Model P1900. | Hill-Rom Inc. | FNL | ||
| Z-1106-04 | Boston Scientific brand Nephroureteral Stent System. Contents: 1-8Fr percuflex catheter... | Boston Scientific Corporation | GBO | ||
| Z-1021-05 | EMCEE OBTURATOR (7F) for use with 8F Sheath, REF #92580008, packaged in individual... | Boston Scientific Corporation | DYB | ||
| Z-1342-04 | PENTRA 120 and PENTRA 120 Retic Hematology Analyzer | Horiba Instruments Incorporated | GJH | ||
| Z-1314-04 | medical device and software systems | Varian Medical Systems, Inc. | MUJ | ||
| Z-1523-05 | E-Z-EM brand, Basic biopsy tray, catalog no. 4125. | North Coast Medi-Tek | LRO | ||
| Z-1044-04 | Argon Medical Devices, Vesseloops, Blue Maxi, Two Latex free silicone vessel ties... | Argon Medical Devices, Inc | KDC | ||
| Z-1064-04 | Osmetech OPTI-CCA Blood Gas Analyzer, Single Use, BP7564 OPTIE-Glu Cassettes.The... | Opti Medical Systems Inc | CGA | ||
| Z-0305-05 | Tibial Base Plates | Smith & Nephew, Inc. | KRO | ||
| Z-0304-05 | Genesis Uni Articular Inserts | Smith & Nephew, Inc. | HSX | ||
| Z-1159-04 | Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000 | Alsius Corp. | NCX | ||
| Z-1079-04 | Emission Computed Tomography System | Philips North America LLC | KPS | ||
| Z-1114-04 | Pencil Point Spinal Tray, Lot number 0504243 | Spinal Specialties, Inc. | LRO | ||
| Z-1337-04 | Digital Radiography System, model DFP-8000D | Canon Medical Systems USA, Inc. | JAA | ||
| Z-1103-04 | Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 10 cm, sterile, single use... | Boston Scientific Corporation | FGE | ||
| Z-1102-04 | Boston Scientific/Microvasive brand Biliary Stent Kit, 7 FR x 5 cm, sterile, single use... | Boston Scientific Corporation | FGE | ||
| Z-1063-04 | Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin... | Roche Diagnostics GmbH | DIP | ||
| Z-1113-04 | Gertie Marx PainPak, Lot number 0504305, Reorder number 4060 | Spinal Specialties, Inc. | LRO | ||
| Z-1036-04 | Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900... | Advance Medical Designs Inc | JAA | ||
| Z-1062-04 | Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin... | Roche Diagnostics GmbH | DIP | ||
| Z-1058-04 | CryoValve Aortic Valve and Conduit | Artivion, Inc. | MIE | ||
| Z-1057-04 | CryoValve Pulmonary Valve and Conduit | Artivion, Inc. | MIE | ||
| Z-1056-04 | CryoValve Pulmonary Valve SG | Artivion, Inc. | MIE | ||
| Z-1091-04 | ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012... | Medtronic, Inc. | --- | ||
| Z-1037-04 | STAAR Surgical Intra Occular Lens, Collamer. | Staar Surgical AG | HQL | ||
| Z-1478-04 | ACOM.M angiographic x ray system. Model numbers 5215707 | Siemens Medical Solutions USA, Inc. | |||
| Z-1477-04 | ACOM.M angiographic x ray system. Model number 4371741 | Siemens Medical Solutions USA, Inc. | |||
| Z-1105-04 | Boston Scientific/MEDI-TECH brand Fascial Dilator, 10 FR (3.3 mm), sterile, single use... | Boston Scientific Corporation | DRE | ||
| Z-1104-04 | Boston Scientific/MEDI-TECH brand Fascial Dilator, 8 FR(2.7 mm), sterile, single use... | Boston Scientific Corporation | DRE | ||
| Z-1076-04 | Dispersive Electrodes packaged in an 8x10 plastic container. | Boston Scientific Corporation | JOS | ||
| Z-1083-04 | VSP Shock Module (as part of a prosthetic foot). | Ossur Americas | ISH | ||
| Z-0043-05 | The MDA system with MDA Antithrombin III MDA Heparin | bioMerieux, Inc. | JPA | ||
| Z-0884-04 | STS-T Mobile x-ray system used with the STS-T lithotripter. | Medstone International Inc |